- Design and execute experiments to further develop downstream processes including:
- Continuous centrifugation and depth filtration development
- TFF optimization and characterization
- Chromatography screening, optimization, and characterization
- Scaling studies
- Development of a scale-down model
- Lead initiatives and tasks for downstream process characterization studies.
- Operate and maintain instrumentation for polysaccharide purification including automated TFF systems, Akta chromatography skids, automated filtration units and continuous centrifuges.
- Perform analysis and interpret results for polysaccharide and impurity assays (Anthrone, Lowry, SEC-MALS, HPAEC-PAD).
- Keep accurate and current records of development experiments and/or project related activities in laboratory notebooks or electronic notebook, prepare technical reports, summaries of testing, and detailed protocols.
- Present/communicate data to polysaccharide team as well as cross-functional teams.
- Research literature to identify novel methodologies and solve scientific problems which apply to the overall program.
- Review executed protocols and batch records and support tech transfer purification processes to external manufacturing groups.
- Writes, reviews, and approves R&D protocols, batch records, and reports in support of process development, and assay development.
- May have direct reports in the future. Works within a team environment and provides support as necessary to further the team's initiatives.
Requirements: - PhD in Bioprocess Engineering, Chemical Engineering, Biotechnology, or a related discipline, with 5+ years of industry experience or combination of industry and postdoctoral research; M.S. with 8+ years of industry experience; or B.S. with 10+ years of industry experience.
- Strong understanding of the principals of DOE (Design of Experiments); practical experience with DOE software; proficient in the design and interpretation of statistically modelled experiments.
- In-depth late-stage process characterization development experience (Risks assessments, CPP Identification, PAR, PC study report writing).
- Practical experience with and theoretical knowledge of traditional processing unit operations including TFF, depth filtration, continuous centrifugation, and chromatography.
- Demonstrated leadership on a project initiative and/or management of a team. Has successfully worked in a cross-functional team environment on multiple projects; ability to work effectively as a member of a team to deliver results.
- Proficient with engineering principles involved in scaling processes from lab to pilot scale as well as developing a scale-down model.
- Proficient with computer programs such as JMP, Microsoft Excel, Word, PowerPoint, Visio.
- Working knowledge of the requirements of GMPs.
- Experience working with CDMOs and ability to effectively communicate experimental design and results to a CDMO.
- Ability to travel internationally to a CMO as some international travel may be required.
- Strong interpersonal skills, with excellent written and verbal communication skills.
- Prior experience in polysaccharide development is a plus.
Reports to: Associate Director, Downstream Polysaccharide Development and Manufacturing
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $150,000 – $169,000 -
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Sr. Engineer, Polysaccharide Downstream Process Development - San Carlos, United States - Vaxcyte, Inc.
Description
Join our Mission to Protect HumankindVaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it Our work together is guided by four enduring core values:
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
Vaxcyte is looking for an energetic and talented Sr. Engineer/Scientist to contribute to the Polysaccharide development and manufacturing group within the CMC team. Vaxcyte is developing a multi-valent polysaccharide-based conjugate vaccine, based on a novel carrier protein produced using the Xpress CF platform. Polysaccharides are a critical component in conjugate vaccines.
The successful candidate will have extensive experience in downstream purification early-stage development and late-stage process characterization. The candidate will have a strong understanding of DOE experimental design, execution, and analysis with statistical software (e.g. JMP). The candidate has demonstrated leadership on a project initiative and/or management of a team. The candidate will be eager to utilize and learn new laboratory skills as this person will be responsible for collaboration on experimental design and execution of experiments to further the polysaccharide development and manufacturing programs. This position will require > 50% time in the lab and this person will be able to independently detail experimental procedures/results in written and presentation formats. The successful candidate will interface closely with the CMC team, write detailed technical reports, present experimental results internally, and interface with external CMO partners.
Essential Functions:
